Last Updated: November 8, 2026

Details for New Drug Application (NDA): 078527

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NDA 078527 describes FLUMAZENIL, which is a drug marketed by Baxter Hlthcare Corp, Dr Reddys, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Rising, Sagent Pharms, and Sandoz, and is included in nine NDAs. It is available from ten suppliers. Additional details are available on the FLUMAZENIL profile page.

The generic ingredient in FLUMAZENIL is flumazenil. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the flumazenil profile page.

Summary for 078527

Tradename:	FLUMAZENIL
Applicant:	Hikma Farmaceutica
Ingredient:	flumazenil
Patents:	0

Pharmacology for NDA: 078527

Medical Subject Heading (MeSH) Categories for 078527

Antidotes
GABA Modulators

Suppliers and Packaging for NDA: 078527

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUMAZENIL	flumazenil	INJECTABLE;INJECTION	078527	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9683	0143-9683-10	10 VIAL, MULTI-DOSE in 1 BOX (0143-9683-10) / 10 mL in 1 VIAL, MULTI-DOSE (0143-9683-01)
FLUMAZENIL	flumazenil	INJECTABLE;INJECTION	078527	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9684	0143-9684-10	10 VIAL, MULTI-DOSE in 1 BOX (0143-9684-10) / 5 mL in 1 VIAL, MULTI-DOSE (0143-9684-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.5MG/5ML (0.1MG/ML)
Approval Date:	Mar 23, 2009	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/10ML (0.1MG/ML)
Approval Date:	Mar 23, 2009	TE:	AP	RLD:	No

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